David Sell

STAFF WRITER

Perhaps only in the strange business of pharmaceuticals would a company sue to have a federal agency declare that one of its products was in any way unsafe and then be disappointed when it loses the the suit.

But that's what happened with Endo Pharmaceuticals, Inc., a subsidiary of Endo Health Solutions, Inc., of Chadds Ford.

The drug in question is Opana ER, which is an opioid painkiller. That group of medicine has been a source of debate because of overdoses by abusers.

The Centers for Disease Control and Prevention recently said, "Although many types of prescription drugs are abused, there is currently a growing, deadly epidemic of prescription painkiller abuse. Nearly three out of four prescription drug overdoses are caused by prescription painkillers — also called opioid pain relievers. The unprecedented rise in overdose deaths in the US parallels a 300% increase since 1999 in the sale of these strong painkillers. These drugs were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined."

Endo's suit against the U.S. Food and Drug Administration was dismissed Wednesday in federal court in Washington.

U.S. District Court Judge Reggie B. Walton did not agree with Endo, "which argued that the FDA failed to meet its legal obligation to determine in a timely manner whether the original formulation of Opana ER was withdrawn from the market for reasons of safety," according to Endo's statement.

Walton ruled against Endo, noting that he believed the FDA has not unduly delayed making a determination on the matter.

With the uproar over overdoses, Endo developed what it says is a more crush-resistant version. (Addicts were crushing and smoking it.)

The FDA argued against Endo's demand for the safety determination by Dec. 31 and an injunction stopping approval of any new generics based on the older version of Opana ER.

The FDA was not convinced that Endo was only concerned with health of would-be overdosers, since it had not recalled the original formulation of Opana ER. It simply stopped marketing it after the new version was on the market. And the FDA argued that Endo's insistence that the FDA say the old version was withdrawn for safety reasons by Dec. 31 was more a tactic to delay another generic company from entering the market on Jan. 1, 2013.

One generic is already on the market (and Endo is suing that company), but Impax Pharmaceuticals is set to start selling its version on Jan. 1. Impax, like other generics, had negotiated a settlement of a patent infringement suit with Endo in 2010. (These arrangements are examples of the pay-to-delay settlements that the Supreme Court will hear arguments about in 2013.)

Endo was arguing that since a generic drug has to conform to the branded drug on which it is based, generics must match Endo's new non-crushable version.

Including a batch of objections related to arcane agency regulations, the FDA said it had no legal requirement to meet Endo's deadline, but it would rule by May on Endo's citizen's petition on this topic, as per rules about citizen's petitions.

"The December 31 'deadline' reflects only Endo’s commercial concern that, as a

result of a settlement agreement it made with another manufacturer, it will face additional

generic competition beginning January 1, 2013," the FDA attorneys wrote in a memo submitted as part of their objection to the suit and request for an injunction. "Endo’s self-inflicted timeline does not trump the statute and does not justify the emergency relief it seeks."

Dave Holveck, president and chief executive officer of Endo Health Solutions, said in a statement that the company was "extremely disappointed" by the decision.

"Despite the fact that the generic product will not be therapeutically equivalent to the crush resistant formulation, the launch of a generic non-crush-resistant version of Opana ER in January will irreparably undermine the significant progress made in the reduction of abuse and misuse of oxymorphone," Holveck said in the statement. "We are hopeful that FDA will ultimately make the right decision before May in light of the surveillance data supporting that the original formulation of Opana ER was discontinued for reasons of safety."